Localized delivery of drug agents

• US 6,939,320 B2
• Filed: 06/27/2001
• Issued: 09/06/2005
• Est. Priority Date: 05/18/1998
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Lennox, Charles D.
• Primary Examiner(s): Thanh, LoAn H.
• Application Number:
  US09/891,420
• Publication Number:
  US 20010035456A1
• Time in Patent Office: 1,532 Days
• Field of Search: 604/93.01, 604/96.01, 604/101.01, 604/101.02, 604/101.03, 604/101.04, 604/102.02, 604/103, 604/103.01, 604/103.03, 604/103.05, 604/103.06, 604/103.08, 60410311-10313, 604/915, 604/916, 604/917, 604/919, 606/192, 606/194
• US Class Current: 604/103.02
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61L 2300/606 Coatings
• CPC Class Codes: A61L 29/085 Macromolecular materials
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/1088 having special surface characteristics depending on material properties or added substances, e.g. for reducing friction
• CPC Class Codes: A61M 25/1027 Making of balloon catheters
• CPC Class Codes: A61M 25/104 used for angioplasty
• CPC Class Codes: G06Q 20/04 Payment circuits
• CPC Class Codes: G06Q 20/108 Remote banking, e.g. home banking
• CPC Class Codes: G06Q 20/16 Payments settled via telecommunication systems
• CPC Class Codes: G06Q 20/223 based on the use of peer-to-peer networks
• CPC Class Codes: G06Q 20/24 Credit schemes, i.e. "pay after"
• CPC Class Codes: G06Q 20/26 Debit schemes, e.g. "pay now"
• CPC Class Codes: G06Q 20/28 Pre-payment schemes, e.g. "pay before"
• CPC Class Codes: G06Q 20/3223 Realising banking transactions through M-devices
• CPC Class Codes: G06Q 20/325 using wireless networks
• CPC Class Codes: G06Q 20/40 : Authorisation, e.g. identification of payer or payee, verification of customer or shop credentials; Review and approval of payers, e.g. check credit lines or negative lists

Abstract

Medical devices including a substrate that are expandable from a compressed state to an expanded state; a coating on the substrate, the coating having a drug agent incorporated therein; and a sheath over the coating. The sheath is expandable from a compressed state to an expanded state and has at least one perforation therein. The medical devices are configured such that when the substrate is in a compressed state, the sheath is also in a compressed state and the perforation is substantially closed. When the substrate is in an expanded state, the sheath is also in an expanded state and the perforation is substantially open. The invention also includes a method of using the medical devices for the controlled, localized delivery of a drug agent to a target location within a mammalian body.

Claims

1. A medical device, comprising:

a substrate that is expandable from a compressed state to an expanded state;

a coating on said substrate, said coating having a drug agent incorporated therein, wherein said drug agent comprises an anti-proliferative agent and is incorporated in said coating prior to delivering said medical device to a target location within a mammalian body; and

an elastic sheath over said coating, said elastic sheath being expandable from a compressed state to an expanded state and having at least one perforation therein;

wherein when said substrate is in a compressed state, said elastic sheath is in a compressed state and said at least one perforation is substantially closed such that said drug agent does not pass through said at least one perforation; and

wherein when said substrate is in an expanded state, said elastic sheath is in an expanded state and said at least one perforation is substantially open such that said drug agent passes through said at least one perforation.

2. The device of claim 1, wherein said coating comprises a polymer selected from the group consisting of polycarboxylic acids, cellulosic polymers, gelatin, polyvinylpyrrolidone, maleic anhydride polymers, polyamides, polyvinyl alcohols, polyethylene oxides, glycosaminoglycans, polysaccharides, polyesters, polyacrylamides, polyethers, polyurethane dispersions, acrylic latex dispersions, and mixtures and copolymers thereof.

3. The device of claim 1, wherein said elastic sheath comprises a material selected from the group consisting of ethylene vinyl acetate, latexes, urethanes, polysiloxanes, styrene-ethylene/butylene-styrene block copolymers, aliphatic polyesters, and mixtures and copolymers thereof;

and nitinol and stainless steel.

4. The device of claim 1, wherein said at least one perforation is in the shape of a longitudinal slit.

5. The device of claim 4, wherein said elastic sheath comprises a plurality of perforations arranged in a staggered pattern.

6. The device of claim 1, wherein said substrate comprises at least part of a balloon portion of a balloon catheter.

7. The device of claim 6, wherein said elastic sheath is tubular and surrounds said balloon portion of said balloon catheter, said tubular elastic sheath having proximal and distal ends.

8. The device of claim 7, wherein said proximal and distal ends of said elastic sheath are attached to said balloon catheter such that said balloon portion is completely covered by said elastic sheath.

9. The device of claim 8, wherein said proximal and distal ends of said elastic sheath are attached to said balloon catheter by an adhesive.

10. The device of claim 8, further comprising a filament around said proximal and distal ends of said elastic sheath.

24. The medical device of claim 1, wherein said anti-proliferative agent comprises an agent selected the group consisting of paclitaxel, 5-fluorouracil, cisplatin, vinblastine, vincristine, epothilones, endostatin, angiostatin and thymidine kinase inhibitors or a combination thereof.

25. The medical device of claim 24, wherein said anti-proliferative agent comprises paclitaxel.

11. A method for the localized delivery of a drug agent to a target location within a mammalian body, comprising the steps of:

providing a medical device comprising;

a substrate that is expandable from a compressed state to an expanded state;

a coating on said substrate; and

an elastic sheath over said coating, said elastic sheath being expandable from a compressed state to an expanded state and having at least one perforation therein;

wherein when said substrate is in a compressed state, said sheath is in a compressed state and said at least one perforation is substantially closed; and

wherein when said substrate is in an expanded state, said sheath is in an expanded state and said at least one perforation in said expandable sheath is substantially open;

incorporating said drug agent into said coating, wherein said drug agent comprises an anti-proliferative agent;

delivering said medical device to said target location while said elastic sheath is in a compressed state and said at least one perforation is substantially closed; and

expanding said substrate to thereby expand said elastic sheath to an expanded state such that said at least one perforation is substantially open, whereby the drug agent passes through said at least one perforation.

12. The method of claim 11, wherein said step of incorporating the drug agent into said coating comprises the steps of:

expanding said substrate to thereby expand said elastic sheath such that said at least one perforation is substantially open;

exposing said drug agent to said coating through said at least one perforation while said at least one perforation is substantially open; and

compressing said substrate to thereby compress said elastic sheath such that said at least one perforation is substantially closed.

13. The method of claim 12, wherein said drug agent is exposed to said coating by immersing at least part of said medical device into a solution comprising said drug agent.

14. The method of claim 11, wherein said coating comprises a polymer selected from the group consisting of polycarboxylic acids, cellulosic polymers, gelatin, polyvinylpyrrolidone, maleic anhydride polymers, polyamides, polyvinyl alcohols, polyethylene oxides, glycosaminoglycans, polysaceharides, polyesters, polyacrylamides, polyethers, polyurethane dispersions, acrylic latex dispersions, and mixtures and copolymers thereof.

15. The method of claim 11, wherein said elastic sheath comprises a material selected from the group consisting of ethylene vinyl acetate, latexes, urethanes, polysiloxanes, styrene-ethylene/butylene-styrene block copolymers, aliphatic polyesters, and mixtures and copolymers thereof;

and nitinol and stainless steel.

16. The method of claim 11, wherein said at least one perforation is in the shape of a longitudinal slit.

17. The method of claim 16, wherein said at least one perforation comprises a plurality of perforations arranged in a staggered pattern.

18. The method of claim 11, wherein said substrate comprises at least part of a balloon portion of a balloon catheter.

19. The method of claim 18, wherein said elastic sheath is tubular and surrounds said balloon portion of said balloon catheter, said tubular elastic sheath having proximal and distal ends.

20. The method of claim 19, wherein said proximal and distal ends of said elastic sheath are attached to said balloon catheter such that said balloon portion is completely covered by said elastic sheath.

21. The method of claim 11, wherein said medical device comprises an electroporation catheter.

22. The method of claim 11, wherein said medical device comprises an iontophoresis catheter.

26. The method of claim 11, wherein said drug agent comprises an anti-proliferative agent.

27. The method of claim 26, wherein said anti-proliferative agent comprises an agent selected the group consisting of paclitaxel, 5-fluorouracil, cisplatin, vinblastine, vincristine, epothilones, endostatin, angiostatin and thymidine kinase inhibitors or a combination thereof.

28. The method of claim 26, wherein said anti-proliferative agent comprises paclitaxel.

29. The medical device of claim 28, wherein said anti-proliferative agent comprises paclitaxel.

23. A medical device, comprising:

a catheter comprising a balloon portion that is expandable from a compressed state to an expanded state;

a polymer coating on said balloon portion, said coating having a drug agent incorporated therein, wherein said drug agent comprises an anti-proliferative agent and is incorporated in said coating prior to delivering said medical device to a target location within a mammalian body; and

a tubular elastic sheath over said coating, said elastic sheath being expandable from a compressed state to an expanded state and having a plurality of perforations therein, said perforations being arranged in a staggered pattern;

wherein

the proximal and distal ends of said elastic sheath are attached to said catheter such that said balloon portion is completely covered by said elastic sheath;

when said balloon portion is in a compressed state, said elastic sheath is in a compressed state and said perforations are substantially closed such that said drug agent does not pass through said perforations; and

when said balloon portion is in an expanded state, said elastic sheath is in an expanded state and said perforations are substantially open such that said drug agent passes through said perforations.